Endovascular anastomotic connector device, delivery system, and methods of delivery and use

ABSTRACT

An endovascular anastomotic connector and method of using the same. The endovascular anastomotic connector includes a vascular conduit and a supply conduit. The vascular conduit has proximal and distal ends that reside within a vascular structure. The supply conduit extends at an angle from the vascular conduit. The proximal end of the supply conduit is configured to be attached to an auxiliary device.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of application Ser. No. 12/829,425filed Jul. 2, 2010 (pending) which claims the priority of U.S.Provisional Patent Application Ser. No. 61/242,153, filed on Sep. 14,2009 (expired), the disclosures of which are incorporated by referenceherein.

TECHNICAL FIELD

The present invention relates generally to vascular connector devicesand methods of using the same. More specifically, the invention relatesto an endovascular anastomotic connector, a delivery system, and amethod of delivery.

BACKGROUND

The circulatory system of the human body transports blood containingchemicals, such as metabolites and hormones, and cellular waste productsto and from the cells. This organ system includes the heart, blood, anda vascular network. Veins are vessels that carry blood toward the heartwhile arteries carry blood away from the heart. The human heart consistsof two atrial chambers and two ventricular chambers. Atrial chambersreceive blood from the veins and the ventricular chambers, which includelarger muscular walls, pump blood from the heart. Movement of the bloodis as follows: blood enters the right atrium from either the superior orthe inferior vena cava and moves into the right ventricle. From theright ventricle, blood is pumped to the lungs via pulmonary arteries tobecome oxygenated. Once the blood has been oxygenated, the blood returnsto the heart by entering the left atrium, via the pulmonary veins, andflows into the left ventricle. Finally, the blood is pumped from theleft ventricle into the aorta and the vascular network.

In some instances, it becomes necessary to maintain fluidiccommunication with the vascular network. For example, a circulatoryassist system uses a pump to aid in moving blood through the vascularnetwork, thereby relieving the symptoms associated with congestive heartfailure (commonly referred to as heart disease). The pump of thecirculatory assist system includes inflow and outflow cannulae. Oftenthe inflow cannula connects the left atrium of the heart to the pump;the outflow cannula connects the pump to a peripheral artery. Theoutflow cannula must be stabilized within the peripheral artery toensure proper functioning of the circulatory assist system and reducethe risk of bleeding. Accordingly, it would be beneficial to havedevices that can be delivered and secured to a peripheral vessel but arealso capable of being attached to an auxiliary device.

SUMMARY

In one illustrative embodiment of the present invention, an anastomoticconnector is described. The anastomotic connector includes a vascularconduit and a supply conduit. The vascular conduit has proximal anddistal ends that reside within a vascular structure. The supply conduitextends at an angle from the vascular conduit. The proximal end of thesupply conduit is configured to extend from the vascular structure andattach to an auxiliary device.

In another illustrative embodiment of the present invention, a deliverysystem is described and includes the anastomotic connector and adelivery subassembly. The delivery subassembly includes a multi-lumenhub, a multi-lumen delivery shaft, and a secondary delivery shaft. Themulti-lumen delivery shaft extends from the multi-lumen hub, through thelumen of the supply conduit, and out from the distal end of the vascularconduit. The secondary delivery shaft extends from the multi-lumen hub,into the proximal end of the vascular conduit, and out from the distalend of the vascular conduit. A proximal portion of the secondarydelivery shaft extending from the distal end of the vascular conduit isreceived by a first lumen of the multi-lumen delivery shaft.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a diagrammatic view of a circulatory assist system with theoutflow of the pump being connected to a peripheral artery with anendovascular anastomotic connector, shown in partial cross-section.

FIG. 1A is a side-elevational view, in partial cross section, of theendovascular anastomotic connector in a peripheral artery.

FIG. 2 is a side-elevational view, in partial cross section, of adelivery subassembly for advancing and deploying the endovascularanastomotic connector.

FIG. 3 is a side-elevational view, in partial cross section, of amulti-lumen delivery shaft of the delivery subassembly.

FIG. 4A is a cross-sectional view of the multi-lumen delivery shafttaken along the line 4A-4A of FIG. 3.

FIG. 4B is an isometric view of the multi-lumen delivery shaft with thesecondary delivery shaft taken from the enclosure 4B of FIG. 2.

FIG. 5 is a partial side-elevational view, in partial cross section, ofthe multi-lumen hub and a luer adapter of the delivery subassembly.

FIG. 6 is a side-elevational view of the secondary delivery shaft of thedelivery subassembly.

FIG. 7A is a side-elevational view of one exemplary method of loadingthe endovascular anastomotic connector onto the delivery subassembly.

FIG. 7B is a side-elevational view, in partial cross section, of thedelivery assembly.

FIG. 7C is a cross-sectional view of one exemplary method of folding theendovascular anastomotic connector around the delivery subassembly,taken along the line 7C-7C of FIG. 7B.

FIGS. 8 and 9 are side-elevational views illustrating successive stepsof one exemplary procedure for loading the delivery assembly into adelivery sheath.

FIGS. 10-16 are side-elevational views, in partial cross section,illustrating successive steps of one exemplary procedure for insertingand deploying the endovascular anastomotic connector in a peripheralartery.

FIG. 17 is a side-elevational view, in partial cross section, of thedeployed endovascular anastomotic connector in the peripheral artery.

DETAILED DESCRIPTION

FIG. 1 illustrates an implanted circulatory assist system 10. Forillustrative purposes, certain anatomy is shown including the heart 12of a patient 14 having a right atrium 16, a left atrium 18, a rightventricle 20, and a left ventricle 22. Blood from the left and rightsubclavian veins 24, 26 and the left and right jugular veins 28, 30enters the right atrium 16 through the superior vena cava 32 while bloodfrom the lower parts of the body enters the right atrium 16 through theinferior vena cava 34. The blood is pumped from the right atrium 16, tothe right ventricle 20, and to the lungs (not shown) to be oxygenated.Blood returning from the lungs enters the left atrium 18 via pulmonaryveins 35 and is then pumped into the left ventricle 22. Blood leavingthe left ventricle 22 enters the aortic arch 36 and flows into the leftsubclavian artery 38, the left common carotid 40, and thebrachiocephalic trunk 42 including the right subclavian artery 44 andthe right common carotid 46.

With respect to the implanted circulatory assist system 10, a flexiblecannula body 48 extends from within the left atrium 18, through theintra-atrial septum 50, and percutaneously to a vascular access site 52in the right subclavian vein 26. The flexible cannula body 48 isattached to an input port 54 of an implantable pump 56. An endovascularanastomotic connector 58 connects an output port 60 of the implantablepump 56 to a suitable superficial artery, such as the right subclavianartery 44. The physician can position the implantable pump 56subcutaneously and, optionally, submuscularly in a pump pocket 57located near the vascular access site 52 or maintain the pump 56externally.

The endovascular anastomotic connector 58 is shown in greater detail inFIG. 1A. For illustrative purposes, the endovascular anastomoticconnector 58 is shown to be implanted within the right subclavian artery44; however, any suitable peripheral vessel could be used. Theendovascular anastomotic connector 58 includes a vascular conduit 62 anda supply conduit 64 that extends angularly from the vascular conduit 62.The junction between the vascular and supply conduits 62, 64 forms abifurcation joint 66. In some embodiments, the vascular conduit 62 canbe a vascular stent.

The vascular and supply conduits 62, 64 can each include supportstructures 67, 68, 69 constructed from continuous wire or laser cut froma hypotube or rolled sheet stock. The support structures 67, 68, 69 arethen encapsulated within an expandable material. The expandable materialcan be superelastic and self-expanding, such as nickel titanium (NiTi).Alternatively, a balloon-expandable material, such as nickel cobalt(NiCo) or chromium cobalt (CrCo) can be used. The expandable materialcan then be coated with a porous material to allow for the migration ofendothelial cells, and to secure the conduits 62, 64 to the wall of thevessel. Suitable porous materials can include expandedpolytetrafluoroethylene (ePTFE), woven polyester, velour, or DACRONbrand of synthetic polyester fabric. In some embodiments, the wallthickness of the vascular conduit 62 can be thinner than the wallthickness of the supply conduit 64 to allow the vascular conduit 62 toconform to the lumen of the blood vessel while not obstructing the flowof blood through the vessel. This is more preferred over the reversebecause the vascular conduit 62 is implanted within the vessel and theprofile should be minimized so as to not interfere with blood flow.

The bifurcated joint 66 should be flexible and replicate the vessel'snative compliance. The bifurcated joint 66 can form an angle, θ, whichcan vary from about 5° to about 90° (i.e., perpendicular) depending onthe intended use of the endovascular anastomotic connector 58 and thelocal anatomy.

Turning now to FIG. 2, a delivery subassembly 74 for delivering theendovascular anastomotic connector 58 (FIG. 1A) is shown. The deliverysubassembly 74 includes a multi-lumen delivery shaft 76 and a secondarydelivery shaft 78.

The multi-lumen delivery shaft 76, illustrated alone in FIG. 3, includesa multi-lumen tube 80 having a formed tip 82 and a multi-lumen hub 84.The cross-section of one suitable multi-lumen tube 80 is shown in FIG.4A and includes primary and secondary lumens 86, 88, both of whichextend from the distal formed tip 82 to the multi-lumen hub 84. Theprimary lumen 86 is sized to receive a conventional guide-wire. Thesecondary lumen 88 is sized to receive the secondary delivery shaft 78and can be slotted to aid in assembly as will be described below. Themulti-lumen tube 80 can be constructed by an extrusion process from athermoplastic material. The formed tip 82 minimizes trauma to vasculartissues as the delivery subassembly 74 is advanced through the vascularnetwork.

FIG. 4B is an enlarged view of one manner by which the secondary lumen88 of the multi-lumen delivery shaft 76 receives a portion of thesecondary delivery shaft 78, as illustrated in FIG. 2.

FIG. 5 illustrates, in greater detail, the multi-lumen hub 84. Themulti-lumen hub 84 can be molded directly onto the proximal end of themulti-lumen tube 80 or molded separately and then affixed to themulti-lumen tube 80 with an epoxy or a biocompatible adhesive, such asUV or cyanoacrylate. A luer adaptor 90 is connected to a first lumen 92for flushing the primary lumen 86 (FIG. 4) of the multi-lumen tube 80prior to implantation. A second lumen 94 of the multi-lumen hub 84 issized to receive the secondary delivery shaft 78.

FIG. 6 illustrates the secondary delivery shaft 78, which can include asingle lumen tube 96 and a proximal hub luer 98. The single lumen tube96 can be constructed using an extrusion process and can be sized toreceive a conventional guide-wire. The hub luer 98 can be separatelyconstructed and attached to the single lumen tube 96 with abiocompatible adhesive or epoxy. The hub luer 98 allows flushing of thesecondary delivery shaft 78 prior to insertion.

FIGS. 7A-7C illustrate one method of loading the endovascularanastomotic connector 58 onto the delivery subassembly 74. It should benoted that the delivery subassembly 74 has been rotated 180° about alongitudinal, lengthwise axis for illustrating the loading and deliveryof the endovascular anastomotic connector 58.

In FIG. 7A the multi-lumen delivery shaft 76 is directed into theproximal end of the supply conduit 64. The formed tip 82 is advancedthrough the supply conduit 64 until it exits from the distal end 72 ofthe vascular conduit 62. The secondary delivery shaft 78 is advancedthrough the second lumen 94 of the multi-lumen hub 84, along the outsideof the supply conduit 64, and into the proximal end 70 of the vascularconduit 62. The distal end of the secondary delivery shaft 78 is thenadvanced beyond the distal end 72 of the vascular conduit 62 and clippedinto the slotted secondary lumen 88 of the multi-lumen tube 80. Theassembled delivery system 100 is shown in FIG. 7B.

The endovascular anastomotic connector 58 can be folded about thedelivery subassembly 74 to minimize the delivery system profile. Onemanner of folding the endovascular anastomotic connector 58 includescollapsing the support structures 67, 69 (FIG. 1A) of the distal end 72of the vascular conduit 62 and the supply conduit 67, respectively andwrapping the distal end 72 and the supply conduit 67 around themulti-lumen delivery shaft 76. Then, after the secondary delivery shaft78 is inserted through the proximal end 70 of the vascular conduit 62,the support structure 68 is collapsed and the proximal end 70 is wrappedaround the supply conduit 64 in a “c” shape, as shown in FIG. 7C. Inthis way, the vascular conduit 62 can be deployed and positioned withinthe vessel before the supply conduit 64 seals the incision in the wallof the vessel.

After assembly, the delivery system 100 is back-loaded into a deliverysheath 102, as shown in FIG. 8. The delivery sheath 102 can beconstructed from a peel-away sheath design for ease of removal. FIG. 9illustrates the delivery system 100 loaded within the delivery sheath102.

One manner of inserting the endovascular anastomotic connector 58 into avessel can now be described with reference to FIGS. 10-16. The methodbegins with the physician creating an incision 103 into a suitableperipheral vessel, illustrated here as the right subclavian artery 44.The selection of the peripheral vessel is dependent on the particularsurgical procedure. For example, in the implantation of the circulatoryassist system 10 (FIG. 1), the right subclavian artery 44 can beappropriate when the pump pocket 57 (FIG. 1) is located near the rightsubclavian vein 26. An introducer 104 can be directed into the rightsubclavian artery 44 to maintain the incision 103 into the vessel. Asuitable introducer 104 could include those that are commerciallyavailable or a custom introducer, such as the one disclosed in U.S.Provisional Patent Application No. 61/163,931, filed on Mar. 27, 2009,the disclosure of which is incorporated herein by reference. Theillustrated introducer 104 includes a sheath 106 with a proximal hub108. The hub includes a side port 110 and a valve 112 for fluidicaccess.

The physician can then create a secondary incision site (not shown) thatis remotely located from the incision 103 in the right subclavian artery44. For the incision 103 in the right subclavian artery 44, a suitablesecondary incision site could be, for example, near the right femoralvein (not shown). A first guide-wire 114 is then directed percutaneouslyfrom the secondary incision site to the right subclavian artery 44 andthrough the introducer 104. The first guide-wire 114 is then directedinto the distal end of the secondary delivery shaft 78. In someembodiments, the physician can direct the first guide-wire 114 throughthe entire length of the secondary delivery shaft 78, alternatively thefirst guide-wire 114 is advanced about 10 mm to about 20 mm into thesecondary delivery shaft 78.

As shown in FIG. 11, a second guide-wire 116 is advanced through theprimary lumen 86 (FIG. 4) of the multi-lumen tube 80 until it extendsdistally from the formed tip 82. The second guide-wire 116 is thenadvanced into the right subclavian artery 44 via the introducer 104.

With the guide-wires 114, 116 in position, the delivery system 100 withthe delivery sheath 102 can be advanced, as a unit, into the introducer104, as shown in FIG. 12, while the positions of the guide-wires 114,116 and the introducer 104 are maintained. The delivery system 100 isadvanced until the formed tip 82 is positioned as shown in FIG. 13,i.e., the formed tip 82 should be positioned distal to the deliverysheath 102 and within the right subclavian artery 44. In someembodiments, the formed tip 82 can include one or more radiopaquemarkers for in vivo visualization under a suitable viewing device duringthe positioning procedure. The physician then additionally, oralternatively, visualizes the positioning of the support structures 67,68, 69 within the artery 44 (refer again to FIG. 1A). One such properposition can place the vascular conduit 62 just distal to the incision103.

FIG. 14 illustrates the removal of the delivery sheath 102 to deploy theendovascular anastomotic connector 58. In embodiments where the deliverysheath 102 is constructed from a peel-away sheath design, the deliverysheath 102 is removed by pulling the ends 118, 120 of the deliverysheath 102 apart.

Once the delivery sheath 102 is sufficiently removed, the endovascularanastomotic connector 58 automatically deploys within the rightsubclavian artery 44. The proximal end 70 of the vascular conduit 62 isunfolded from around the supply conduit 64 and radially expanded againstthe inner wall of the right subclavian artery 44 by the supportstructure 67 (FIG. 1A). The supply conduit 64 can remain constrained bythe sheath 106 of the introducer 104 during this manipulation.

As illustrated in FIG. 15, the first guide-wire 114 is retracted fromits position within the secondary delivery shaft 78 and is advancedthrough the vascular conduit 62 and beyond the proximal end 70. Thesecondary delivery shaft 78 can then be removed.

The physician can then pull proximally on the multi-lumen delivery shaft76 and the supply conduit 64 to reposition the vascular conduit 62 andbridge the incision 103 in the wall of the right subclavian artery 44.Repositioning is structurally supported by the multi-lumen deliveryshaft 76. The introducer 104 and the multi-lumen delivery shaft 76 canthen be retracted from the right subclavian artery 44 leaving theendovascular anastomotic connector 58, as shown in FIG. 16.

FIG. 16 further illustrates the proximal and distal ends 70, 72 of thevascular conduit 62 each including a flare (shown in phantom), whichallows the vascular conduit 62 to accommodate a wider range of vesselsizes and to provide for a smooth transition between the vascularconduit 62 and the vessel.

Once the sheath 106 of the introducer 104 is removed, the supportstructure 69 (FIG. 1A) of the supply conduit 64 will cause the supplyconduit 64 to automatically expand radially, as shown in FIG. 17.

Though not shown, the physician can ensure full radial expansion of thesupport structures 67, 68, 69 (FIG. 1A) by advancing a balloon dilationcatheter to the endovascular anastomotic connector 58. The balloondilation catheter can be advanced over the first or second guide-wires114, 116 depending on which portion of the endovascular anastomoticconnector 58 is being expanded. That is, to fully expand the vascularconduit 62, the balloon dilation catheter is advanced over the firstguide-wire 114 and is positioned within the vascular conduit 62 at oneof the support structures 67, 68 (FIG. 1A). The balloon dilationcatheter is inflated and then deflated. The physician can then eitherremove or reposition the balloon dilation catheter at another supportstructure 68, 67 (FIG. 1A) within the vascular conduit 62.

To fully expand the bifurcation joint 66, the physician directs aballoon dilation catheter over the second guide-wire 116. Inflation ofthe balloon dilation catheter causes the bifurcation joint 66 to expandand seal the incision 103 in the wall of the right subclavian artery 44.In some embodiments, the physician can inflate and deflate the balloondilation catheter multiple times, in the same or different positions,within the bifurcation joint 66 to ensure a complete expansion.

The balloon dilation catheter and guide-wires 114, 116 are then removed.The physician can then cap or clamp (not shown) the proximal end of thesupply conduit 64 to prevent bleeding through its lumen. When attachingthe auxiliary device to the supply conduit 64, the physician can deairthe supply conduit 64 by back bleeding or inserting a needle through thecap to draw out the air.

While the present invention has been illustrated by a description ofvarious preferred embodiments and while these embodiments have beendescribed in some detail, it is not the intention of the Applicants torestrict or in any way limit the scope of the appended claims to suchdetail. Additional advantages and modifications will readily appear tothose skilled in the art. The various features of the invention may beused alone or in any combination depending on the needs and preferencesof the user. This has been a description of the present invention, alongwith the preferred methods of practicing the present invention ascurrently known. However, the invention itself should only be defined bythe appended claims.

What is claimed is:
 1. A delivery system comprising the anastomoticconnector of claim 1 and a delivery subassembly, the deliverysubassembly comprising: a multi-lumen hub; a multi-lumen delivery shaftconfigured to extend from the multi-lumen hub, through the lumen of thesupply conduit, through the lumen of the distal end of the vascularconduit, and distally from the distal end of the vascular conduit; and asecondary delivery shaft configured to extend from the multi-lumen hub,into the proximal end of the vascular conduit, through the lumen of thevascular conduit, and distally from the distal end of the vascularconduit, wherein a distal portion of the secondary delivery shaft isreceived by a first lumen of the multi-lumen delivery shaft.
 2. Thedelivery system of claim 1, wherein the first lumen is slotted andconfigured to receive the secondary delivery shaft.
 3. The deliverysystem of claim 1, wherein the multi-lumen delivery shaft furtherincludes a second lumen for receiving a guide-wire.
 4. The deliverysystem of claim 1 further comprising: a delivery sheath configured toreceive the delivery system and to move relative thereto.
 5. Thedelivery system of claim 4, wherein the delivery sheath is constructedof a peel-away sheath design.
 6. A delivery system for a bifurcatedstent having a body portion and a branch portion extending angularlyfrom the body portion, the delivery system comprising: a multi-lumenhub; a multi-lumen delivery shaft configured to extend from themulti-lumen hub, through a lumen of the branch portion, through thelumen of a distal end of the body portion, and distally from the distalend of the body portion; and a secondary delivery shaft configured toextend from the multi-lumen hub, into a proximal end of the bodyportion, through the lumen of the body portion, and distally from thedistal end of the body portion, wherein a distal portion of thesecondary delivery shaft is received by a first lumen of the multi-lumendelivery shaft.
 7. The delivery system of claim 6 further comprising: adelivery sheath configured to receive the delivery system and to moverelative thereto.
 8. A method of connecting a peripheral vessel to anauxiliary device with an anastomotic connector comprising a vascularconduit and a supply conduit, the vascular conduit having proximal anddistal ends and is configured to reside within the peripheral vessel,the supply conduit having proximal and distal ends, wherein the distalend of the supply conduit forms a bifurcation joint with the vascularconduit and the proximal end of the supply conduit is configured tocouple to the auxiliary device, the method comprising: loading theanastomotic connector onto a delivery subassembly; directing thedelivery subassembly with the anastomotic connector into the peripheralvessel; deploying the vascular conduit within the peripheral vessel;deploying the supply conduit; retracting the delivery subassembly; andconnecting the auxiliary device to the proximal end of the supplyconduit.
 9. The method according to claim 8, wherein loading theanastomotic connector includes wrapping the proximal end of the vascularconduit around the supply conduit.
 10. The method according to claim 8,wherein the delivery subassembly comprises: a multi-lumen hub; amulti-lumen delivery shaft configured to extend from the multi-lumenhub, through a lumen of the supply conduit, through a lumen of thedistal end of the vascular conduit, and distally from the distal end ofthe vascular conduit; and a secondary delivery shaft configured toextend from the multi-lumen hub, into the proximal end of the vascularconduit, through a lumen of the vascular conduit, and distally from thedistal end of the vascular conduit, wherein a distal portion of thesecondary delivery shaft is received by a first lumen of the multi-lumendelivery shaft.
 11. The method according to claim 10 further comprising:creating an incision into the peripheral vessel and maintaining theincision with an introducer before directing the delivery subassemblywith the anastomotic connector into the peripheral vessel.
 12. Themethod according to claim 11 further comprising: directing a firstguide-wire through a second lumen of the multi-lumen delivery shaft,into the introducer, and into the peripheral vessel; and advancing thedelivery subassembly with the anastomotic connector over the firstguide-wire and into the peripheral vessel.
 13. The method according toclaim 12 further comprising: creating a secondary incision site that isremotely located from the incision in the peripheral vessel; directing asecond guide-wire percutaneously from the secondary incision site to theanastomotic connector within the peripheral vessel; and directing thesecond guide-wire through the vascular conduit after the vascularconduit is deployed.
 14. The method according to claim 8, wherein thedelivery subassembly is received by a delivery sheath and moves relativethereto.
 15. The method according to claim 14, wherein the deployingsteps include retracting the delivery sheath.
 16. The method accordingto claim 8, wherein the vascular and supply conduits include supportstructures constructed from a continuous wire, a hypotube, or a rolledsheet stock.
 17. The method according to claim 16 further comprising:directing a balloon dilation catheter through the supply conduit to thevascular conduit, after the delivery subassembly is retracted; inflatingthe balloon dilation catheter to expand the support structures of thevascular conduit; and deflating and removing the balloon deliveryconduit before connecting the auxiliary device to the proximal end ofthe supply conduit.
 18. The method according to claim 16 furthercomprising: directing a balloon dilation catheter into the supplyconduit after the delivery subassembly is retracted; inflating theballoon dilation catheter to expand the support structures of the supplyconduit at the bifurcation joint; and deflating and removing the balloondelivery catheter before connecting the auxiliary device to the proximalend of the supply conduit.
 19. The method according to claim 8 furthercomprising: capping a proximal end of the supply conduit afterretracting the delivery subassembly.
 20. The method according to claim19 further comprising: deairing the supply conduit before removing thecap and connecting the auxiliary device.
 21. The method according toclaim 8, wherein the auxiliary device is a pump.
 22. A method ofconnecting a peripheral vessel to an auxiliary device with ananastomotic connector comprising a vascular conduit and a supplyconduit, the vascular conduit having proximal and distal ends and isconfigured to reside within the peripheral vessel, the supply conduithaving proximal and distal ends, wherein the distal end of the supplyconduit forms a bifurcation joint with the vascular conduit and theproximal end of the supply conduit is configured to couple to theauxiliary device, the method comprising: (i) coupling the anastomoticconnector to a delivery subassembly, the delivery subassembly comprisinga multi-lumen hub, a multi-lumen delivery shaft extending distally formthe multi-lumen hub, and a secondary delivery shaft extending distallyfrom the multi-lumen hub, wherein a distal portion of the secondarydelivery shaft is received by a first lumen of the multi-lumen deliveryshaft, the coupling including: (a) directing the multi-lumen deliveryshaft from the proximal end of the supply conduit, through the lumen ofthe supply conduit, through the lumen of the distal end of the vascularconduit, and distally from the distal end of the vascular conduit; (b)directing the secondary delivery shaft into the distal end of thevascular conduit, through the lumen of the vascular conduit, anddistally from the distal end of the vascular conduit, wherein a distalportion of the secondary delivery shaft is received by a first lumen ofthe multi-lumen delivery shaft; (c) wrapping the proximal end of thevascular conduit around the supply conduit; and (d) backloading thecoupled anastomotic connector with the delivery subassembly into adelivery sheath; (ii) directing the delivery sheath with the coupledanastomotic connector and delivery subassembly into the peripheralvessel; (iii) retracting the delivery sheath to thereby deploy theproximal and distal ends of the vascular conduit within the peripheralvessel; (iv) continuing the retracting to deploy the supply conduit; (v)retracting the delivery sheath and the delivery subassembly from theanastomotic connector; (vi) deairing the supply conduit; and (vii)connecting the auxiliary device to the proximal end of the supplyconduit.